DHS 157.72(2)(d)(d) A licensee shall submit a written report to the department within 15 days after discovery of a dose to the embryo, fetus or nursing child that requires a report in par. (a) or (b). The written report shall include all of the following information: DHS 157.72(2)(d)6.6. What actions, if any, have been taken or are planned to prevent recurrence. DHS 157.72(2)(d)7.7. Certification that the licensee notified the pregnant individual or mother or the mother’s or child’s responsible relative or guardian, and if not, why not. DHS 157.72(2)(d)8.8. The report may not contain the individual’s or child’s name or any other information that could lead to identification of the individual or child. DHS 157.72(2)(e)(e) A licensee shall provide notification of the event to the referring physician and also notify the pregnant individual or mother, both hereafter referred to as the mother, no later than 24 hours after discovery of an event that would require reporting under par. (a) or (b), unless the referring physician personally informs the licensee either that he or she will inform the mother or that, based on medical judgment, telling the mother would be harmful. A licensee is not required to notify the mother without first consulting with the referring physician. If the referring physician or mother cannot be reached within 24 hours, a licensee shall make the appropriate notifications as soon as possible thereafter. A licensee may not delay any appropriate medical care for the embryo, fetus or nursing child, including any necessary remedial care as a result of the event, because of any delay in notification. To meet the requirements of this paragraph, the notification may be made to the mother’s or child’s responsible relative or guardian instead of the mother. If a verbal notification is made, the licensee shall inform the mother, or the mother’s or child’s responsible relative or guardian, that a written description of the event can be obtained from the licensee upon request. A licensee shall provide such a written description if requested. DHS 157.72(2)(f)1.1. Annotate a copy of the report provided to the department with all of the following information: DHS 157.72(2)(f)1.a.a. Name of the pregnant individual or the nursing child who is the subject of the event. DHS 157.72(2)(f)1.b.b. Identification number or if no other identification number is available, the social security number of the pregnant individual or the nursing child who is the subject of the event. DHS 157.72(2)(f)2.2. Provide a copy of the annotated report to the referring physician, if other than the licensee, no later than 15 days after the discovery of the event. DHS 157.72(3)(3) Reports of leaking sources. A licensee shall submit a written report to the department within 5 working days if a leakage test required by s. DHS 157.62 (5) reveals the presence of 185 Bq (0.005 mCi) or more of removable contamination. The written report shall include the model number and serial number, if assigned, of the leaking source, the radionuclide and its estimated activity, the results of the test, the date of the test and the action taken. DHS 157.72(4)(4) Reports for an eluate exceeding permissible molybdenum-99, strontium-82, and strontium-85 concentration. DHS 157.72(4)(a)(a) The licensee shall notify by telephone the department and the distributor of the generator within 7 calendar days after discovery that an eluate exceeded the permissible concentration listed in s. DHS 157.63 (3) (a) at the time of generator elution. The telephone report to the department must include all of the following information: DHS 157.72(4)(a)1.1. The manufacturer, model number, and serial or lot number of the generator. DHS 157.72(4)(a)3.3. Whether dosages were administered to patients or human research subjects. DHS 157.72 NoteNote: A report may be submitted to the department via telephone at (608) 267-4797.
DHS 157.72(4)(b)(b) A licensee who makes a report required by par. (a) shall submit a written report within 30 days of the initial telephone report containing all of the following information: DHS 157.72(4)(b)3.3. The methodology used to make the dose assessment if the eluate was administered to patients or human research subjects.